AZ’s Seroquel back on track for EU nod in MDD

AstraZeneca’s antipsychotic Seroquel has been recommended for approval by advisors to the European Medicines Agency as an add on therapy in major depression, putting the drug back on track for a green light in the region in this setting.

Specifically, the Committee for Medicinal Products for Human Use has issued the thumbs up for approval of Seroquel XR (quetiapine fumarate) to treat major depressive episodes in patients with major depressive disorder, following an inadequate response to other antidepressants.

The news is particularly sweet for the Anglo-Swedish firm given that, last year, the Netherlands Health Authority - acting as reference state for the European Union's mutual recognition procedure - turned down the firm’s application to market the drug in this setting because of uncertainty over its benefit-risk profile.

However, refusing to take this decision lying down, AstraZeneca quickly referred its marketing application to the CHMP directly to seek central approval instead, and the move seems to have paid off as the group has now concluded that the benefit-risk equation for once-daily Seroquel XR is positive after all.

Seroquel XR has racked up a substantial number of approvals in schizophrenia, bipolar mania, bipolar depression, bipolar maintenance, Generalised Anxiety Disorder, and in MDD, and news that the drug is a step closer to winning a green light in Europe as an add-on for MDD will be welcome indeed, especially as the group’s big-earning Seroquel franchise is expected to face generic competition from September next year.

Meanwhile, according to The New York Times the drugmaker has agreed to pay $520 million to lay to rest claims by the US Department of Justice that it marketed Seroquel (quetiapine) for so called off-label uses.